Below we have listed the top seven topics that we receive continual queries about. 

Dynamic Testing.

Dynamic testing verifies the execution flow of software, including decision paths , inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software.  Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible.

Static Analysis.  

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods . One such method is static analysis. This somewhat new method largely automates the software verification process.  The technique attempts to identify errors in the code, but does not necessarily prove their absence.  Static analysis is used to identify potential and actual defects in source code.

Abstract Interpretation Verification.

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the pharmaceutical regulators.

 Revalidation Scheduled.

There is no regulatory requirement to re-validate a process as long as that process operates in a state of GMP control and no changes have been made to the process or output product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-day process control data and any finished device testing data for conformance with specifications and for variability.

Revalidation on Relocation.

When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the re-qualification, the manufacturer can determine whether there have been any changes in equipment performance  as a result of the move. Changes in equipment performance should be evaluated to determine whether it is necessary to revalidate the process.

 Revalidation Justification.

Part 820.75  of the QS  regulation requires that validated processes be monitored and controlled so that when changes or process deviations occur, a manufacturer will know to review and evaluate the process and perform revalidation when appropriate.   21 CFR 820.75(c ) requires you to have documented procedures in place for evaluating; when revalidation is required.

Procurement and Validation.

Recent research has highlighted that in the pharmaceutical and bio-medical industry, thirty two percent of all equipment procurements are unsatisfactory.  The major problem has been identified as companies not specifying in sufficient detail and or accuracy, what their actual needs are.  The lack of a quality company approved User Requirements Specification (URS) , leads to many companies having to resort to otherwise un-necessary and costly retrospective  actions in modifying the equipment or producing unspecified documentation or engineering drawings, post procurement.  These extraneous GMP requirements often cost more than the equipment.

Combination IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment. It is an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to facilitate ease of final editing by the end user. It has become a very popular document.